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Setron medicament oral cavity disintegrating tablet and preparation method thereof

A technology for oral disintegrating tablets and drugs, which is applied to the field of oral disintegrating tablets of setron drugs, can solve the problems of having a gritty feeling, affecting the patient's taste and compliance, slow disintegration of preparations, etc., and achieves no gritty feeling and good taste. , the effect of small gastrointestinal irritation

Inactive Publication Date: 2012-05-16
QUANTUM HI TECH BEIJING RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In China, the preparation technology of orally disintegrating tablets started relatively late. At present, the direct compression method is mostly used to prepare orally disintegrating tablets. Most disintegrants are insoluble in water, so the orally disintegrating tablets prepared by this method often have a gritty feeling after tasting, which affects the taste and compliance of patients when taking it; and the disintegration of the preparation will be very slow

Method used

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  • Setron medicament oral cavity disintegrating tablet and preparation method thereof
  • Setron medicament oral cavity disintegrating tablet and preparation method thereof
  • Setron medicament oral cavity disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] The preparation formula of the present invention is made up of following components:

[0071] Tropisetron Hydrochloride 5.64g

[0072] Glycine 4.40g

[0073] Pullulan 8.40g

[0074] Acesulfame K 0.50g

[0075] Pineapple essence 0.50g

[0076] Purified water 180.56g

[0077] A total of 1000 pieces were made

[0078] The specific preparation method is as follows: mix tropisetron hydrochloride, glycine, pullulan, acesulfame potassium, and pineapple essence evenly, add the purified water of the prescribed amount to it, and mix it with an emulsifier to make a uniform solution; After vacuum degassing, it is accurately injected into the mold; after being frozen in liquid nitrogen at -100°C to -110°C for 6 minutes, it is transferred to a freeze dryer, and freeze-dried for 3 hours at a pressure of 0.05mbar and -20°C to 20°C. That is, the orally disintegrating tablet of tropisetron hydrochloride of the present invention is obtained.

Embodiment 2

[0080] The preparation formula of the present invention is made up of following components:

[0081] Tropisetron Hydrochloride 2.82g

[0082] Mannitol 4.40g

[0083] Pullulan 8.40g

[0084] Aspartame 1.00g

[0085] Purified water 183.38g

[0086] A total of 1000 pieces were made

[0087] The specific preparation method is as follows: mix tropisetron hydrochloride, mannitol, pullulan, and aspartame evenly, add the purified water of the prescribed amount to it, and mix it with an emulsifier to make a homogeneous solution; vacuum the solution After degassing, pour it into the mold accurately; freeze it at -120°C to -130°C for 3 minutes with liquid nitrogen, incubate at -10°C for 12 hours, transfer it to a freeze dryer, and store it under the conditions of 0.02mbar pressure and -20°C to 20°C Freeze-dry for 3.5 hours to obtain the orally disintegrating tropisetron hydrochloride tablet of the present invention.

Embodiment 3

[0089] The preparation formula of the present invention is made up of following components:

[0090] Tropisetron Hydrochloride 2.82g

[0091] Glycine 2.00g

[0092] Pullulan 2.00g

[0093] Dextran-70 1.00g

[0094] Purified water 192.18g

[0095] A total of 1000 pieces were made

[0096] The specific preparation method is as follows: Mix Tropisetron Hydrochloride, Glycine, Pullulan, and Dextran-70 evenly, add the prescribed amount of purified water to it, mix with an emulsifier to make a uniform solution; vacuum degas the solution After that, it is accurately injected into the mold; after being frozen in liquid nitrogen at -110°C to -120°C for 4 minutes, incubated at -40°C for 2 hours, transferred to a freeze dryer, and frozen under the conditions of 0.1mbar pressure and -20°C to 20°C After drying for 4 hours, the orally disintegrating tablet of tropisetron hydrochloride of the present invention is obtained.

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Abstract

The invention relates to a setron medicament oral cavity disintegrating tablet and a prescription and process for preparing the setron medicament oral cavity disintegrating tablet by adopting a freeze-drying method. The setron medicament oral cavity disintegrating tablet provided by the invention is prepared from a main medicament and pharmaceutical adjuvants. When the setron medicament oral cavity disintegrating tablet is administered, water is not need, and the setron medicament oral cavity disintegrating tablet can be rapidly disintegrated after entering the oral cavity; the setron medicament oral cavity disintegrating tablet is suitable for being taken by the patients with dysphagia such as the elder, children and the like; and meanwhile, the setron medicament oral cavity disintegrating tablet is taken without need of water, thus the symptoms of nausea and vomiting are not aggravated, has better compliance and treatment effect to nausea and vomiting caused by chemotherapy, radiotherapy or operation, and can obviously lower the side effects of setron medicaments. In addition, the invention also relates to a preparation method of the setron medicament oral cavity disintegrating tablet.

Description

Technical field: [0001] The invention relates to an orally disintegrating tablet of a setron-like drug and a preparation method thereof, in particular to an orally disintegrating tablet of a setron-like drug prepared by a freeze-drying method. Background technique: [0002] Chemotherapy and radiotherapy are important and effective means of tumor treatment, but 20% to 30% of patients will experience nausea and vomiting while receiving chemotherapy and radiotherapy, and patients often reduce or even stop treatment due to intolerance. The highly selective 5-HT3 receptor antagonist developed in the 1990s is used for antiemetic during tumor chemotherapy and radiotherapy. breakthrough progress. [0003] Setron drugs are potent and highly selective peripheral and central nervous system 5-HT3 receptor antagonists, which are highly selective for peripheral and central nervous system 5-HT3 receptors, and their anti-emetic mechanism is highly selective Block the abdominal vagus nerve...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K45/08A61J3/00A61P25/00A61P1/08
Inventor 王丛威王洪飞王丽滨王彦峰周立运
Owner QUANTUM HI TECH BEIJING RES INST
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